Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)
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|ClinicalTrials.gov Identifier: NCT01391546|
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : November 20, 2017
Last Update Posted : February 14, 2018
Two co-primary objectives are:
- To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
- To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination
- To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
- To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route
- To describe the safety profile of ZOSTAVAX administered by IM or SC route
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: ZOSTAVAX||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older|
|Actual Study Start Date :||June 20, 2011|
|Actual Primary Completion Date :||October 15, 2012|
|Actual Study Completion Date :||October 15, 2012|
Experimental: ZOSTAVAX intramuscular (IM) route
Single dose of 0.65 mL via IM injection
1 dose 0.65 mL
Other Name: V211
Active Comparator: ZOSTAVAX subcutaneous (SC) route
Single dose of 0.65 mL via SC injection
1 dose 0.65 mL
Other Name: V211
- Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination [ Time Frame: 4 week post-vaccination ]Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination
- Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies [ Time Frame: 4 week post-vaccination ]Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)
- Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ]Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.
- Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction [ Time Frame: up to 28 days after vaccination ]Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.
- Percentage of Participants Who Report at Least 1 Systemic Adverse Event [ Time Frame: up to Day 28 after vaccination ]An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.
- Percentage of Participants Who Report at Least 1 Serious Adverse Event [ Time Frame: up to 35 days after vaccination ]A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391546
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|